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Author:
Brolin, Sandra (Mälardalen University, School of Sustainable Development of Society and Technology)
Title:
Global Regulatory Requirements for Medical Devices
Department:
Mälardalen University, School of Sustainable Development of Society and Technology
Publication type:
Student thesis
Language:
English
Publisher: Akademin för hållbar samhälls- och teknikutveckling
Level:
Independent thesis Basic level (professional degree), 20 points / 30 hp
Undergraduate subject:
Kemiteknik
Uppsok:
teknik
Pages:
51
Year of publ.:
2008
URI:
urn:nbn:se:mdh:diva-700
Permanent link:
http://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-700
Subject category:
Medical Laboratory and Measurements Technologies
SVEP category:
Medical engineering
Keywords(en) :
medical devices, quality, regulations, classification, risk management
Keywords(sv) :
medicinsk teknik, kvalitet, regelverk, klassificering, riskhantering
Abstract(en) :

Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.

The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.

Presentation:
2008-05-14, K338, Verktyget, Smedjegatan 37, Eskilstuna, 09:00
Supervisor:
Zhang, Lian
Examiner:
Hamp, Sven, Universitetslektor (Mälardalen University, School of Sustainable Development of Society and Technology)
Available from:
2008-06-05
Created:
2008-06-05
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